-by Michele Kimball, state director, AARP Minnesota

At the Minnesota State Capitol today, lawmakers are hearing about important proposals to reform the way prescription drugs are prescribed in Minnesota.  AARP is pleased to be part of the Minnesota Prescription Coalition working to help this effort gain the attention it deserves  — and to ultimately pass these important reforms.

Why do we care?
AARP represents about 700,000 consumers in Minnesota over the age of 50.  It comes as no surprise that older Minnesotans have a huge stake in this game because they are the biggest consumers of prescription drugs.

Prices of drugs continue to rise, having a direct negative effect on older and disabled Americans, especially those on fixed incomes. These are the Minnesotans who won’t receive a Social Security cost-of-living increase in 2010 because of low inflation of nearly every other sector of the economy.

Higher drug prices mean that Minnesotans enrolled in Medicare’s Part D drug program more quickly reach the “doughnut hole”—the coverage gap in which they must currently pay the full price of their medications.  To be sure, older consumers want policymakers to do whatever they can to control costs.

But it’s not just about drug costs.  It’s about quality, ethical health care – and about ensuring that our loved ones get the right drug and the right information whenever they visit a doctor.

Kim Witczak’s Story
No one can speak to this issue better than Kim Witczak, a very brave consumer from Minneapolis who has become an expert on prescription drug issues since the death of her husband.

On August 6, 2003, Kim’s husband, Woody died of a Zoloft-induced suicide at age 37. He was not depressed, nor did he have any history of depression or any other mental illness. He died after taking the drug a total of 5 weeks with the dosage being doubled shortly before his death. He was given the antidepressant from his general physician for “insomnia.”

Kim told Minnesota’s lawmakers that Woody loved life. He was a compassionate, loyal husband, son, brother, uncle, godfather and friend. He had endless energy, a constant smile and a laugh that could be heard a mile away. Woody had a successful sales career and had just started his dream job as VP of sales with a start up company. He was excited about this new opportunity and along with this excitement came difficulty sleeping. He went to see his family doctor and after a 5-minute consultation, he was given Zoloft for an insomnia diagnosis.  This was the first time he’d ever gone to a doctor for this sort of issue.   Read more about his story at www.woodymatters.com.

Kim talked about the current way we prescribe drugs and how Woody and his doctor became victims of a system that is too focused on marketing and profits.  Woody was given a 3-week sample of Zoloft by his general practitioner.  Insomnia is an “off-label” use for Zoloft.  Samples are a marketing technique used to promote drugs.

Marketing and Detailing

Too much of the information and research that doctors get about the drugs they prescribe comes from the drug companies’ representatives.  As Allan Coukell of the Pew Prescription Project testified today, spending on marketing and promotional goods by the pharmaceutical industry is estimated at nearly $30 billion – much of it directed at those who prescribe medications.  Drug reps visit the office to discuss the attributes of the drugs and to leave samples.  In fact, between 60-80 percent of all antidepressant prescriptions are written after about a 5-10 minute consultation by general practice or family doctors who may or may not know the significance of all the side effects.

From a consumer’s perspective, educating doctors about new drugs should not be left to marketers.  Doctors need nonbiased information and they need all the research available to know the risks of what they are prescribing.  Patients need to know that their health care providers are delivering the best care possible and that they are not swayed by gifts or other financial incentives.

Marketing and sales practices have no doubt compromised the doctor-patient relationship and have contributed to the skyrocketing costs of prescription drugs and the overall increase in health care costs.

So What Happened Today?
The Minnesota Prescription Coalition and key legislative authors presented three bills today to help reduce the current conflicts or interest between pharmaceutical industry and doctors.

• Legislation that will prohibit pharmaceutical companies from buying doctors’ prescribing records and using the information to target their marketing to individual doctors. Pharmaceutical Data Mining: S.F. 1044 (Sen. John Doll) and H.F. 491 (Rep. Tina Liebling)

• Legislation that will ban gifts to providers from pharmaceutical manufacturers and improve transparency and reporting laws that more clearly define relationships between health care providers and pharmaceutical companies. Pharmaceutical and Medical Device Gift Ban:  S.F. 1237 (Sen. John Marty) and H.F. 1641(Rep. Tina Liebling)

• Legislation to establish an “academic detailing” program to give physicians nonbiased information to make the best and most cost-effective decisions about prescriptions. Independent Prescriber Education Program “Academic Detailing” S.F. 895 (Sen. Kathy Sheran) and H.F. 1640 (Rep. Tina Liebling)

I believe that momentum is growing in Minnesota among consumers, providers and policy experts to establish objective, evidence-based methods of getting accurate information into the hands of physicians and other prescribers.

Dr. Chris McCoy, a physician in Rochester, and policy chair of the National Physicians Alliance spoke about how many doctors feel about the current marketing practices of pharmaceutical companies.  “Trust in the medical profession is slipping away as pharmaceutical companies buy influence through our systems,” said McCoy.  “Families and patients need to trust that doctors are making the best decisions, based on nonbiased information.”

I can tell you from my experience in conversations with AARP members here in Minnesota, frustration about the negative effects of the pharmaceutical industry’s marketing practices is at an all-time high.

We still have a lot of work to do.  The opposition to this legislation is out in force.  I believe that eventually, these bills will prevail.  Minnesotans are a very common-sense lot.  These bills make common sense for consumers, health care providers, insurers and government entities in Minnesota.

Yesterday, the FDA unveiled ‘FDA Basics’, a website tool geared to help the public get to know the FDA staff and what they do. The website will provide explainers to questions about what the agency and its different centers do, videos and profiles of agency leaders, as well as hosted online conversations between FDA officials and the public.

FDA Basics is the first of a three-part transparency initiative that the agency is undertaking under the Obama administration.  In a webinar Tuesday, deputy commissioner Joshua Sharfstein said the Basics site grew out of unsolicited public feedback to the transparency task force seeking more info about how the agency works.

But the site won’t offer the clinical safety and efficacy information on specific drugs that many consumer advocates have called for. That, Sharfstein said, is part of daunting phase two, in which the agency will make recommendations about what information should be made public and accessible  and how — including clinical trials information, recalls, approval and warning letters, and post-market surveillance.  Recent reports (see our blog last week) have highlighted the unavailability of this information to prescribers and the public–even about some of the top-prescribed drugs in the U.S.

Phase three will establish how the agency interacts transparently with regulated industries.

Sharfstein commended the tremendous feedback the agency received on the FDA transparency blog and at the task force’s public hearings, and invited more on the FDA Basics website. In response to a webinar question, he also said that the site should provide information about how to become an advisory committee member for the agency.

Check out FDA Basics here.

–Kate Petersen, PostScript blogger

A review by the Sunlight Foundation found that important safety and other clinical data on more than one-third of the top-prescribed drugs in the U.S. is  not readily available to prescribers, researchers and patients. The transparency watchdog group found that nine of the 25 top-prescribed drugs, including Lipitor, Effexor, and Plavix, lack this online information–meaning most prescribers have an incomplete picture of safety and efficacy on commonly-written scrips.

The data, required by the FDA for approval but often left unpublished in medical journals and other venues, is only online for drugs approved after 1998. Even then, Sunlight reports, the online info may be heavily redacted and is published in manually-created PDFs that “are not hyper-linked or text searchable, and therefore are hard to navigate.” Information on drugs approved before 1998 has to be obtained by the characteristically slow and cumbersome Freedom of Information Act request, a process most physicians don’t use to inform prescribing decisions.

The Foundation says its unclear whether such data will be included as part of the Obama administration’s Open Government Directive, a plan to have each government agency publish previously undisclosed data sets to the public, but drug safety advocates like Dr. Steven Nissen of the Cleveland Clinic say that such drug info should “absolutely” be included.

For more on the review, including a list of the top-prescribed drugs and which data remains inaccessible, read the story here.

–Kate Petersen, PostScript blogger

In a look both back and ahead at the relationships between the pharmaceutical and medical device industry and physicians, Modern Healthcare reports today that transparency has come a long way in the last three years, but there’s still a ways to go to “ensure patient care is free of financially induced bias.”

When the Senate began investigating the issue of payments from pharma and medical device companies to physicians three years ago, many in the industry denied there was a problem, writes Modern Healthcare.  “But now the healthcare industry appears poised, even if reluctant, to remove the veil that has cloaked industry-provider financial ties. An increasing number of provider organizations, medical-device companies and drugmakers have begun voluntarily disclosing those relationships, and the proposed Physician Payments Sunshine Act, which would mandate disclosure, may soon become law as part of Congress’ healthcare overhaul.”

Indeed, major drugmakers like GlaxoSmithKline and the medical device trade organization AdvaMed actively support the Senate bill, which is moving through the health care reform process now. And a number of companies, including GSK, have pledged to voluntarily disclose payments made to physicians and medical groups.

The Pew Prescription Project’s Allan Coukell and other supporters of the Physician Payments Sunshine provisions say that such voluntary disclosure efforts are no stand-in for a uniform and comprehensive transparency law like the Sunshine proposal.  “We’re nowhere near comprehensive disclosure,” Coukell said, “and if you do it company by company the information is not that useable.”

Harvard researcher Eric Campbell concurred, telling Modern Healthcare that when it comes to disclosure, details matter. “The real question is the level and depth of disclosure,” Campbell said, adding that penalties for non-compliance must be significant enough to encourage companies to collect and report the information.

For more about the Physician Payments Sunshine provisions, check out the RxP Sunshine Guide.

–Kate Petersen, PostScript blogger

In this week’s New England Journal of Medicine (subscription required), the office of the Inspector General of Health and Human Services suggests that pooled industry funding for Continuing Medical Education could provide a midterm solution to what the Inspectors hope will be the medical profession’s ultimate decision, to “eschew commercial support for CME.”

Authors Lewis Morris and Julie Taitsman, both counsel to the HHS OIG, ask “what is the best way to ensure that CME serves a bona fide educational purpose, is not co-opted as a marketing tool, and does not violate laws against fraud and abuse?” Their suggestion: a pooled-funding mechanism, whereby drug and device companies would contribute to unrestricted pools of funding controlled by independent grant organizations, who, through a transparent and unbiased process, would “award funding based on the educational merit of the CME programs, without allowing the donors to specify which programs their donations will fund.”

Of course, the authors admit that early signs suggest this is a hard sell to pharmaceutical and medical device companies, whose support for CME has grown 300 percent, and who currently develop and tailor their CME programming to align closely with their product marketing interests. An attempt by the American Academy of Orthopedic Surgeons to create such an independent pool won little company interest.

Still, the authors write, shoring up the independence of CME should be a top concern to the medical profession. “Since the marketing goals of pharmaceutical and device companies can influence CME funding,” they write, “preservation of the academic integrity of CME requires clear boundaries separating education and marketing.”

The HHS Inspector’s office has expressed concern before about the influence of commercial CME funding, and testified in July before a Senate committee on the commercial influence of CME on prescribing and medical practice.

Though the fall of Sen. Byron Dorgan’s drug re-importation bill in the health reform debate earlier this week isn’t news, yesterday’s NPR health blog “Shots” pointed to an analysis of pharma contributions and votes on the re-importation bill by Maplight, a national watchdog group that uses technology to highlight the relationship between financial support and political action. According to the NPR health blog, the Senators “voting nay have averaged 66 percent more in campaign contributions from Big Pharma than senators who voted yea.” Legalizing drug re-importation, which is illegal in the U.S. now, would lower drug costs dramatically – Dorgan estimated $100 billion in consumer savings over the next decade.

Despite the political drama around President Obama’s reversal on the issue of re-importation (he and some Democratic senators took high-visibility stands against the amendment this week, citing issues of drug safety), we hope the commitment the President and these Senators demonstrated to preventing unsafe products from reaching U.S. patients will extend to all the drugs, devices, and ingredients we currently legally import, many coming from countries such as India and China, where regulatory scrutiny is low.

PostScript takes a holiday

Happy tidings, and we’ll see you in 2010!

According to the New York Times, the deal PhRMA struck with the White House and Senate Finance committee this summer in exchange for its support of health reform is now apparently holding up a vote that would allow drugs to be reimported from Canada. The bill, sponsored by North Dakota Sen. Byron Dorgan, has enough votes to make it into the health reform bill. The CBO has said that the bill could save the U.S. $19.4 billion over the next 10 years, though industry and the FDA have voiced concerns that reimported drugs might be susceptible to adulteration.

But Sen. Dorgan says that his bill addresses those concerns.

“U.S. consumers are charged the highest prices in the world for drugs that sell for a fraction of the price in most other countries,” Mr. Dorgan said. “My amendment includes strong safeguards to prohibit drug counterfeiting and other practices that would put the consumer at risk. It applies only to F.D.A.-approved prescription drugs produced in F.D.A.-approved plants from countries with comparable safety standards.”

And two Senators have filed an amendment to the health reform legislation moving through Congress that would prevent drug companies from mining prescriber-identifiable data for marketing purposes, according to the Associated Press. Companies buy physician prescribing data and sell it to pharmaceutical companies, which use it to target their sales pitches. By filing the amendment, sponsors Sens. Kohl (D-WI) and Durbin (D-IL) have raised the national profile of this problematic marketing tactic, which some states have been grappling with for years.

“I think at both  federal and state levels you’ll see continued momentum because it’s clear the issue of drug marketing influence hasn’t been addressed yet,” Community Catalyst’s Marcia Hams told the AP.

In other Senate news, Big Pharma’s epistolary thorn-in-side Sen. Grassley was at it again this week, writing to 33 patient and professional medical groups to ask for details about the industry funding they receive.  Among them, the American Medical Association, the American Cancer Society, and the American Academy of Family Physicians.

Apparently, it’s all how you define industry. AMA spokesman Mike Lynch told the Times that “industry funding comprised less than 2 percent of the organization’s budget,” though last year the organization made a handy $47.6 million licensing physicians’ data, which is then bought by  pharmaceutical companies for data-mining.

“These organizations have a lot of influence over public policy, and people rely on their leadership,” Mr. Grassley told the Times. “There’s a strong case for disclosure and the accountability that results.”

And the St. Louis Post-Dispatch reported earlier this week on how Congress, FDA and consumer groups are looking at ways to curb TV and online direct-to-consumer advertising for patient safety.  Some members of Congress are considering putting a moratorium on ads for new drugs, or lifting the tax break pharma companies currently get on consumer ads. And recently, the FDA requested public comment on how to regulate pharma and medical device companies’ online marketing. At the hearing, the Pew Prescription Project’s Allan Coukell told agency officials that marketing regulations should protect the public health first, and not be loosened for online ads before there is evidence that the public health is being protected by such ads.

“Before the FDA provides a pathway for companies to do a whole new kind of marketing,” he told the Post-Dispatch,” I think they should be looking for evidence of health benefits,” he said.

–by Kate Petersen, PostScript blogger

–by Jonas Hines

The New York Times reported this weekend about a newly-approved cancer drug, Folotyn, for a deadly blood cancer. The catch? It costs about $30,000 per month. Per month. Oh, and it did not prolong life expectancy for patients (though it did shrink tumor size) in the trial that led to its FDA approval in September.

And, as the Times reported last month, the cost of drugs is on the rise—nine percent last year, the highest rate of inflation since 1992. Big Pharma says, predictably, such hikes are necessary for the research of novel drugs (such as Folotyn?). Interestingly, last time major legislation that could impact the cost of drugs was on the table –in 2006 with Medicare Part D– the cost of drugs went up, too.  Is this ramp up simply in anticipation of health care reform legislation? One thing is for sure: The cost of health care is only going up as long as we are using $30,000-a-month drugs to shrink tumors.

As for the drug maker’s take on the cost of its drug? The Times reports: “Mr. Caruso [CEO of Allos Therapeutics, who makes Folotyn] also said the price of Folotyn was not out of line with that of other drugs for rare cancers. Patients, moreover, are likely to use the drug for only a couple of months because the tumor worsens so quickly, he said.”

In other words, because the drug doesn’t prolong life, the exorbitant cost is self-limited.

Jonas Hines is a medical student in New Mexico and a member of the American Medical Student Association. Previously, he held a fellowship at Public Citizen in Washington D.C.

PostScript is a group blog, and a forum for many different opinions on prescription drug issues. The views expressed do not necessarily reflect those of Community Catalyst or of other PostScript authors.

by Ann Woloson, Executive Director, Prescription Policy Choices

Who’s lurking in the shadows of our kid’s computer screen? Marketers, that’s who, including drug companies offering free gifts in exchange for personal information, which in turn, is used for marketing purposes.

Many adults might be surprised and offended to know their personal information, which most assume is private, is frequently being used in such ways.  Now young teens and older children are being targeted via the internet by a whole host of marketers, including pharmaceutical companies.

As a policy maker and a parent, I’m concerned about drug companies reaching out to kids over the internet under the guise of providing information.  Free gifts are offered in exchange for names, addresses, date of birth, and other personal information; which is unknowingly used, shared or sold for marketing purposes.

My concern is not about limiting access to information, especially information kids want about health care they may need.  My concern is over what drug companies do with information they collect from teens. It will be used to market specific drugs to kids–products that might not be necessary or not as safe or effective as others on the market.

While federal law offers some protection to kids under age 13, older children are not protected. A law to help prevent predatory marketing was passed unanimously in Maine last spring.  Its intent was to prevent the retrieval of personal health care-related information from kids that would in turn be used for marketing purposes.  Testimony regarding the proposed law described drug company pop-ups and other ads that lure kids to websites offering free gifts (music downloads, backpacks, coolers, art supplies, lunch boxes, etc), coupons and free samples, in exchange for their personal information.

The law was challenged in court by a number of plaintiffs, including web companies, universities, and newspapers, who were concerned about free speech rights. Colleges were concerned they wouldn’t be able to market programs to students. Newspapers worried they could not report on sports events or kids who make the honor roll.  While drug companies are not named in the challenge, they were represented and provided comment at a legislative committee meeting in Maine where the law was reviewed.

Previous legal cases have established that public speech and commercial speech are provided different protections, especially when states have an interest in protecting the health, safety and welfare of children.

However, it appears, that Maine’s final predatory marketing law may pose unintended problems even though it was amended to address real privacy concerns. For that reason, it’s likely to be repealed and reintroduced with changes allowing legitimate activity, while providing privacy protections teens need to prevent the use of their personal information for unintended purposes.  There needs to be a balance between the right to access information for legitimate purposes, and the right to safeguard and protect the privacy of our children’s personal information.

PostScript is a group blog, and a forum for many different opinions on prescription drug issues. The views expressed do not necessarily reflect those of Community Catalyst or of other PostScript authors.

New Jersey is responding to widely-shared concerns about physician-industry financial relationships with a mix of both tested and newer reforms, and its move toward greater transparency is consistent with national trends.

In a report this week, the state’s Division of Consumer Affairs calls on state agencies to ban pharma meals to physicians, require physicians to disclose industry payments totaling more than $200, and restrict the use of commercial data-mining of prescriber data, one of the main tools in the pharma industry’s marketing arsenal.

New Jersey’s Board of Medical Examiners has been exploring these issues seriously and comprehensively for some time, holding public hearings on pharma issues like gifting, conflict of interest policies at academic medical centers, and industry-backed continuing medical education. (The Prescription Project testified before the Board on industry marketing in Nov. 2007.)

In general, we favor measures that put the compliance requirements on the industry, rather than on physicians. Because New Jersey puts the onus on doctors, it is possible that its approach will do more than existing laws in other states to discourage certain problematic relationships. However, it may also be more difficult to ensure compliance. In the main, though, New Jersey is to be congratulated for these innovative efforts to curb inappropriate influence on prescribers.

We’re going group!

After two years, PostScript is graduating to a group blog. There’s more about Rx policy than we can say ourselves, so from time to time—starting next week—we’ll open this space to other voices on pharmaceutical issues.

Stay tuned…

–Kate Petersen, PostScript blogger

Will CME providers be included in the Sunshine provisions of health care reform? The Wall Street Journal looked at the question recently. The final House health reform bill includes CME providers and other third-party medical groups among the covered recipients whose payments from the pharmaceutical and medical device industry would be publicly disclosed—language referred to as the Physician Payments Sunshine provisions. The Senate Finance bill that is being merged now with the HELP committee  also contained Sunshine provisions, but did not include third-party groups.

Yet representatives of industry-backed CME in Washington whom the Journal spoke to seem to understand that good transparency means broad transparency, and that broad transparency is becoming a requisite for credibility in the medical education industry.

Indeed, since the Sunshine Act was introduced in January 2009 as a stand-alone bill that would require drug and device companies to disclose all payments to doctors and others, acknowledgment of a need for national medical transparency standards has gained wide acceptance. The Institute of Medicine and the Medicare Payment Advisory Commission have both recommended that third-party medical groups like CME providers be among those whose payments from industry should be disclosed; the IOM called for an end to all company support of such education programs within two years. As the Journal points out, companies such as Pfizer and GlaxoSmithKline have stopped direct support of for-profit third-party CME providers.

–Kate Petersen, PostScript blogger